Trial document




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  DRKS00017687

Trial Description

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Title

Music-assisted treadmill training in the therapy of Parkinson's disease

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Trial Acronym

MATT study

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Parkinson’s Disease (PD) is one of the main neurodegenerative disease in Germany and in western industry nations with increasing number of patients due to the demographic change. In the course of the disease PD patients suffer from motor and non-motor symptoms. Only a limited number of pharmacotherapies for the symptomatic treatment of PD patients are available and so is the invasive deep brain stimulation (DBS), which is limited to a selected group of patients. Inducing an urgent need for alternative, non-pharmacologic therapy options.
Motor and cognitive therapies are established treatments, however in the usual care routines they are applied independent (if at all) from on another even though a growing understanding of motor function and cognition as linked entities exists. Furthermore patient’s motivation for long-term adherence can be a challenge in progressive disease.
Treadmill training and cueing are successfully applied in routine care of PD patients to improve gait. Patients consider the training with musically auditive cues as especially motivating. A music assisted gait training showed better effects than a usual treadmill training. However, these studies mainly focused on motor functional outcomes, so that a remaining research interest exists to examine the possible effects on cognition. Furthermore, studies rarely include patient-centered outcomes, so that the current project aims at evaluation these. Additionally there is little evidence about the mid-term effects of a music-assisted treadmill training so that these will be evaluated as well.
In the current pilot-project with a randomized controlled design and follow-up telephone interview after six weeks, we aim at the evaluation of feasibility as well as short- and mid-term effects of a music-assisted treadmill training on cognition. Furthermore the patient-centered outcomes of mood, motivation, fatigue, and fun will be compared to an usual ergometer training.

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Forwarding of patient-related data:

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017687
  •   2019/09/25
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  •   yes
  •   Approved
  •   19-1291, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1240-9458 
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Health Condition or Problem studied

  •   G20 -  Parkinson disease
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Interventions/Observational Groups

  •   20 min music assisted treadmill training plus regular motor and cognitive rehabilitation therapy for 8 training days
  •   20 min ergometertraining plus regular motor and cognitive rehabilitation therapy for 8 training days
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cognition
- Overall cognition (MoCA)
- Alertness (TAP)
- selective Attention (TAP)
- reaction time (WTS, RT-S5)
- Inhibition (TAP)
- cognitive flexibility (TAP; TMT B/A)
- word fluency (RWT)
- short-term memory (number and Digit span of WMS-R; visual reproduction of WMS-R)
- working memory (number and Digit span of WMS-R)
- mentale rotation (LPS-2, Subtest 7)
- visual scanning (TAP, TMT- A)
- learning strateges (CVLT; TOL-D)

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Secondary Outcome

Motor Function
- gros motor function: Fist Closure Frequency
- fine motor function: NHPT
- Balance/ risk for falls: BBS; TUG; TUG+DT
- gait: 10mGT
- Freezing: FoGQ
- functional independence: FIM

Ability to sychronize

Motivation, mood, fatigue und fun while training

Disease severity (H&Y; UPDRS)

Depression (GDS)

Quality of life (PDQ-39; EQ-5D)

Activity level (IPAQ)

Fatigue (PFS- 16)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/09/26
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
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Additional Inclusion Criteria

- Patients with Parkinson's disease
- no further neurological or psychiatric disease, that interferes with study participation
- no hint at a medium severe depression(cut-off: < 10 Points on Geriatric Depression Scale)
- no other disease (cardiologic or orthpedic), that interferes with study participation
- undisturbed or sufficiently corrected vision and hearing
- Participant speaks German
- Patient can provide informed consent (cut-off: Montreal Cognitive Assessment (MoCA) > 17 points; Freitas et al., 2014)
- Patient can follow therapeutic instructions
- Patient provides written consent for study participation
- scheduled stay of at least 14 days at neurological rehabilitations center Godeshöhe e.V.

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Exclusion Criteria

- severe disturbtion of vigilance, of speech or psychiatric, which interfere with understanding of study aims and/ or instructions, and decrease safety during
- daily uncontrolled changes in medication or Stimulation Settings, which would decrease safety

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Addresses

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    • Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Prof. Dr. rer. nat.  Elke  Kalbe 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Neurologisches Rehabilitationszentrum Godeshöhe e. V.
    • Mr.  Diplom Psychologe  Jochen  Saliger 
    • Waldstr. 2-10
    • 53177  Bonn
    • Germany
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    • Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Prof. Dr. rer. nat.  Elke  Kalbe 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Medizinische Psychologie | Neuropsychologie und Gender Studies Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  MSc  Mareike  Gooßes 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Psychologie | Neuropsychologie und Gender Studies und Centrum für Neuropsychologische Diagnostik und Intervention (CeNDI)
    • Ms.  Prof. Dr. med  Elke  Kalbe 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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